Institution decisions at the Board are rarely changed, and cannot be appealed. Following institution, the timeline for trial is fast and unforgiving. But what happens when the Board leaves its institution decision open to modification in the future? This is the scenario playing out in an ongoing IPR trial.
Despite black-letter law that IPRs can only resolve patentability based on prior art patents and printed publications, enablement and written description support can be key issues, particularly in life sciences patents with functional antibody claims. A final written decision in Daiichi Sankyo Company Limited v. Alethia Biotherapeutics, Inc. (IPR2015-00291) found such claims unpatentable after finding that the priority application failed to pass muster from a § 112 standpoint, but that the invention was disclosed in a reference published after the priority document was filed but before the filing of the continuation-in-part that was challenged.
Intex, a swimming pool manufacturer, challenged its competitor’s air purge valve patent by petitioning for IPR. The Board instituted trial, despite Bestway, the patent owner, raising questions about whether some of the references asserted in the petition were prior art that could be relied on in IPR.
The CAFC has recently focused attention on the use of functional claim language—that is, claim language that describes what an element does, rather than describing what the element is. A recent IPR showed how functional claiming can play out at the PTAB, where it is often the case that neither the petitioner nor the patent owner wants the claims to be construed as employing “means-plus-function” language. For the petitioner, such an interpretation would make it more difficult to show invalidity. For the patent owner, such an interpretation could substantially narrow the scope of the claim and have a significant downstream impact on the patent owner’s ability to show infringement. But the PTAB may have its own ideas about how to interpret the claims.
The U.S. Supreme Court today issued what had the potential for being the most significant case to impact one of the most significant additions to patent law in our lifetimes. At issue in Cuozzo Speed Technologies, LLC v. Lee was the way the Patent Office’s Patent Trial and Appeal Board (PTAB) and the courts have been dealing with a new type of challenge to patents, made available in the fall of 2012 under the America Invents Act (AIA). AIA trials have been sought over 5,000 times to challenge patents and are widely used to resolve patent disputes. Many patent owners complained that these proceedings were unfairly tilted in favor of those challenging patents. Cuozzo sought Supreme Court review of two such practices that it felt went too far and were inappropriate given the language and intent of the AIA. However, the Court sided with the PTAB on both issues, leaving the AIA trial process, as practitioners have come to know it over the last four years, intact.
Multiple IPRs challenging patents covering brand-name biologics have now been filed by biosimilar developers, for reasons we recently discussed, as well as by other entities. Institution decisions in these early IPRs and a small number of final written decisions suggest that broad mechanistic claims as well as follow-on patent claims—such as those covering methods of treating specific patient populations or specific dose regimens—will be vulnerable to obviousness challenges at the PTAB. However, a tougher time should be expected in challenging composition-of-matter patents.
Last month, the Board weighed in on what it means to be human in a rare decision granting a motion to amend claims in an IPR (IPR2015-00208). The owner of U.S. Patent No. 6,681,897 (which covers a method of handling a wheel of an elevated vehicle to avoid injury) proposed claims in its motion to amend that narrowed the original claims in a number of ways. One addition was to explicitly use the term “human” in referring to who performs the steps of the claims, an addition that may not have been intended to invite deep philosophical discourse. Rather, the patent owner apparently intended to distinguish from the art by excluding methods in which the weight of the wheel is partially supported by a non-human entity, like a hoist, during a carrying step.
Initially, biopharma represented a small percentage of post-grant proceedings; however, that percentage is increasing. In particular, generic and biosimilar manufacturers are recognizing advantages of this pathway. The high success rates achieved so far are compelling: For biopharma IPR petitions that have reached a final written decision, 66 percent have resulted in some or all of the challenged claims being invalidated.
The Federal Circuit’s recent decision in Merck and Cie v. Gnosis highlights the importance of getting it right the first time at the PTAB. In its decision, the Federal Circuit denied Merck’s request for the whole court to consider raising the legal standard by which the court reviews the PTAB’s decisions. By denying the petition, the Federal Circuit left in place the system of deferential review that makes changing the outcome of a PTAB trial more difficult than challenging a decision from a district court.
Last week, the U.S. Supreme Court heard oral arguments in Cuozzo Speed Technologies v. Lee. At issue in this appeal is the fundamental nature of IPR—is it an efficient means to cull bad patents that shouldn’t have been issued in the first place, or is it a cost-effective substitute for district court litigation? While we’ll have to wait until June for the final decision to learn the answer, the Justices’ questions highlight some of their concerns.